What are the biggest challenges for manufacturers of single-use bioreactors?
Mr. Abellan: Manufacturing disposable equipment having high-quality/high-tech control systems at the same time is a big challenge, since these manufacturing processes need different core competencies.
Single-use sensors still have a lack of performance and, therefore, sometimes do not meet the needs for high-performance process control. Also finding materials free from leachables/extractables is still a challenge.
Another challenge is to manufacture single-use bioreactors that encompass microbial culture with, for example, high oxygen demand or a larger pH range than is possible with single-use equipment at the moment. The limits here are clearly the higher requirements for material stability and higher performance sensors, similar to nondisposable solutions.
Dr. Arnold: Well, it’s a question of philosophy. What kind of solutions and technology do you want to rely on to serve the users of single-use bioreactors? As a manufacturer that aims to provide single-use bioprocess solutions that can be easily adapted to proven processes and workflows in each customer’s lab, we see only one main challenge: we believe we need to combine the advantages and features of both single-use and conventional bioreactor technologies to create products that allow users to gain the most reliable and scalable results.
For us, developing single-use bioreactors means transferring the geometry and control capabilities established in glass and stainless steel bioreactor technology to new materials in the form of advanced polymers.
Mr. Clapp: The first challenge is the realization that single-use bioreactors are not the same as their SIP counterparts. A single-use bioreactor is composed of two highly integrated elements: the equipment and the bag assembly. An appropriate amount of specification and review takes place (by the end-user, owner, etc.) for the bag assemblies—usually.
Quite often, however, more scrutiny is placed on the equipment element than is necessary. In so doing, the full value of single-use bioreactors has not been realized by the industry. And, it is not limited only to bioreactors.
The second challenge is that balancing standardization, intellectual property, and commercial success will be critical to the pace and extent of innovation and progress. There are many lessons to be learned from SIP bioreactors so that old mistakes are not repeated and new ones may be avoided
Mr. Giroux: The two main challenges are the inertia of the biopharmaceutical industry in embracing change. The high costs of implementing changes and the risks associated with making such changes result in slow adoption of technologies that may be ultimately beneficial to the end user’s bottom line.
Another issue revolves around educating the users about all of the benefits of single-use technologies. Much of the advantage of single-use systems comes from their flexibility, small footprint, and ease of use, but these benefits must be understood to be realized.
Dr. Golightly: Lack of standardization represents a challenge to both suppliers and consumers: end-users would prefer both the flexibility and potential cost benefits of interchangeability, but suppliers are presently determined to introduce value-adding differentiation.